The Senior Toxicologist utilizes their scientific expertise and regulatory experience to lead nonclinical development programs with guidance from her/his direct supervisor working effectively within cross-functional project teams. The Sr. Toxicologist will demonstrate a thorough understanding of GLP regulations and FDA/EMEA/ICH nonclinical safety guidelines to independently lead the design, conduct, interpretation, and reporting of regulatory toxicology and/or exploratory pharmacology/toxicology studies in rodent and non-rodent safety models. The Sr. Toxicologist will provide primary authorship of all regulatory documentation required for submission packages, demonstrating excellent problem solving and communication skills (written and verbal).
Experience with multiple therapeutic modalities preferred, including antibody, oligonucleotide, and genetherapy products.
JOB RESPONSIBILITIES:
Represent toxicology on global research and development project teams communicating non-clinical safety assessment strategy.
Coordinate cross-department execution of the experimental plan including program budgets, and timing of toxicology studies in relation to regulatory and clinical milestones.
Work with study monitoring group to coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
Communicate toxicology study findings, including relevant interpretation, to project teams and management.
Contributing to non-clinical sections of regulatory documents including IND and NDA submissions.
Maintain currency with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines.
Keep up with the latest scientific developments by reading the current literature and attending conferences.
JOB REQUIREMENTS:
Senior Toxicologist • Cambridge, MA
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